- alveolar rhabdomyosarcoma - or synovial sarcoma who are in first or second complete remission or partial response, metastatic sarcomas of the following types: - Ewing sarcoma, The trial will include patients with so called "fusion-driven"
Conditions
Brief summary
Primary endpoint is "success of treatment", defined as the patient showing a vaccination-induced T cell response to either of the two patient specific peptides without unacceptable toxicity until Follow-up visit (28 ± 7 days after last vaccination)
Detailed description
A) CD8+ and/or CD4+ T-cell responses measured 2-fold above background in response to either of the two patient-specific peptides (fusion-peptide and mutation-based neopeptide)., B)CD8+ and/or CD4+ T-cell responses measured 2-fold above background in response to either of the two patient-specific peptides after completion of the study at day 180., C) Event-free (EFS) at day 180., D) Overall survival (OS) at day 180, E) Quality of life during study treatment.
Interventions
DRUGIPX vaccine
Sponsors
Universitaetsklinikum Tuebingen AöR
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is "success of treatment", defined as the patient showing a vaccination-induced T cell response to either of the two patient specific peptides without unacceptable toxicity until Follow-up visit (28 ± 7 days after last vaccination) | — |
Secondary
| Measure | Time frame |
|---|---|
| A) CD8+ and/or CD4+ T-cell responses measured 2-fold above background in response to either of the two patient-specific peptides (fusion-peptide and mutation-based neopeptide)., B)CD8+ and/or CD4+ T-cell responses measured 2-fold above background in response to either of the two patient-specific peptides after completion of the study at day 180., C) Event-free (EFS) at day 180., D) Overall survival (OS) at day 180, E) Quality of life during study treatment. | — |
Countries
Germany
Outcome results
None listed